A Prospective Randomized Study of Three Expanded Polytetrafluoroethylene (PTFE) Grafts as Small Arterial Substitutes

Abstract

A prospective, double-blind, randomized study was performed to determine the relative patency rate of polytetrafluoroethylene (PTFE) grafts, Gore-Tex,® Impra,® and a Surgikos® prototype PTFE graft. The 48 grafts (40 × 4 mm) replaced excised segments of femoral arteries in adult mongrel dogs, whose mean weight was 20.6 ± 0.9 kg; the grafts were removed after 12 weeks. Sterile technique and antibiotic therapy were included in the study. Anticoagulation was not employed. Anastomoses were performed with 6 = 0 polypropylene. Angiographic assessment of each anastomosis was made at surgery and prior to sacrifice. Patency was assessed daily by palpation and Doppler flow signals, as well as angiographically, prior to sacrifice. The overall patency rate was 62.5%. There were no statistically significant differences in patency rates among the three groups (Gore-Tex, 56%; Impra, 75%; Surgikos, 56%). Histologic evaluation revealed incomplete neointima formation and significant pannus formation in all three types of grafts without any significant discernible difference among them. The results suggest that further experimental evaluation of PTFE, as a small vessel substitute, is indicated prior to its use clinically in preference to autogenous vein.